In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine...more
3/14/2024
/ Alabama ,
Criminal Liability ,
Genetic Materials ,
Healthcare ,
Human Embryos ,
Life Sciences ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
Women's Rights ,
Wrongful Death
On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et...more
On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also...more
Introduction -
Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more
8/10/2023
/ 21st Century Cures Act ,
Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Interstate Commerce ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Software
We’ve all heard troubling stories involving emerging tools powered by artificial intelligence (AI), in which algorithms yield unintended, biased, or erroneous results. Here are a few examples:
- A monitoring tool for...more
6/8/2023
/ Algorithms ,
Artificial Intelligence ,
Bias ,
Consumer Product Companies ,
Employer Liability Issues ,
Facial Recognition Technology ,
Health Care Providers ,
Life Sciences ,
Privacy Laws ,
Race Discrimination ,
Risk Management ,
Webinars
On January 23, 2023, CMS published in the Federal Register its first proposed rulemaking to implement the Medicare Drug Price Negotiation Program (the “Negotiation Program”), which is included in the Inflation Reduction Act...more
Changes are on the horizon for provisions of the Program of All-Inclusive Care for the Elderly (PACE) that haven’t been updated in over a decade.
What exactly is PACE and how will new proposed rule modifications affect PACE...more
In celebration of the 50th episode of our Diagnosing Health Care podcast, we’re looking at how the past 50 years of health law will impact health care in the next 50 years.
On this episode, Epstein Becker Green attorneys...more
A recent decision by the U.S. District Court for the District of Columbia has clarified that a Medicare beneficiary may challenge a Medicare Local Coverage Determination (LCD) without first having to exhaust the lengthy...more
The Centers for Medicare & Medicaid Services (CMS) Office of Minority Health has published its comprehensive CMS Framework for Health Equity 2022–2032 (Framework). CMS’s Framework arose in response to the Biden...more
On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more
On July 13, 2021, the Biden administration (“Administration”) officially published the “Requirements Related to Surprise Billing; Part I”—its first regulatory response to the enactment of the No Surprises Act (“NSA”)—as an...more
This Diagnosing Health Care episode dives into the prospects of coverage expansion following the 2020 elections and also examines three major health care policy reform issues that have bipartisan support and could see...more
10/22/2020
/ Billing ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Legislative Agendas ,
Medicare ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Presidential Elections ,
Relief Measures ,
Surprise Medical Bills
Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more
1/9/2020
/ Artificial Intelligence ,
Biologics ,
Clinical Trials ,
Electronic Medical Records ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance ,
Healthcare Facilities ,
Hospitals ,
Investment Opportunities ,
Long Term Care Facilities ,
Medical Devices ,
Medicare Advantage ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Private Equity ,
Research and Development ,
Telehealth ,
Telemedicine
On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule titled “Nondiscrimination in Health Programs and Activities” (“Proposed Rule”)[1] to implement the nondiscrimination...more
10/15/2015
/ Affordable Care Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Federally Facilitated Exchanges ,
Health Care Providers ,
Health Insurance Exchanges ,
Healthcare ,
OCR ,
Proposed Regulation ,
Public Comment ,
State Health Insurance Exchanges
On September 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced[1] the opportunity for plan sponsors to test value-based insurance design (“VBID”) in the Medicare Advantage (“MA”) market. VBID refers to...more
On May 26, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) containing the first proposed revisions to the Medicaid managed care (“MMC”) program’s regulations in more than...more
On April 10, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a proposed rule (“Proposed Rule”) implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction...more
5/7/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Employer Group Health Plans ,
Healthcare ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Medicare ,
Mental Health ,
Mental Health Parity Rule ,
Proposed Regulation
On February 12, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an updated version of its Medicare Advantage (“MA”) and prescription drug benefit (“Part D”) plan audit protocols and also announced the...more
Medicare Advantage (“MA”) plans, prescription drug plans (“PDPs”), and other stakeholders have until November 3, 2014, to provide input into the Centers for Medicare & Medicaid Services’ (“CMS’s”) consideration of potential...more
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more
6/7/2014
/ Certiorari ,
Dismissals ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Off-Label Use ,
Pharmaceutical Industry ,
Pleading Standards ,
Popular ,
Qui Tam ,
Rule 9(b) ,
SCOTUS ,
Split of Authority ,
Takeda Pharmaceuticals ,
Whistleblowers